(313 days)
- Base/liner
- Pit & Fissure sealant
Bright Flow is a light-cured flowable composite resin. It comprises two different types of flowability (Low Flow and High Flow) and 9 shades depending on the intended use, which enables aesthetic and durable outcomes for anterior and posterior composite restorations.
Here's a summary of the acceptance criteria and the study that proves the device meets them, based on the provided text:
Device Name: Bright High Flow
Manufacturer: GENOSS Co., Ltd.
The provided document describes the performance bench testing and biocompatibility testing conducted to demonstrate that the Bright High Flow device meets its acceptance criteria. No clinical study or MRMC effectiveness study is mentioned, as this device appears to be a dental material.
1. Table of Acceptance Criteria and Reported Device Performance
Biocompatibility Testing
| No. | Test | Acceptance Criteria | Reported Performance |
|---|---|---|---|
| 1 | Cytotoxicity | None cytotoxicity | Pass |
| 2 | Irritation | None oral irritation | Pass |
| 3 | Sensitization | None sensitization | Pass |
| 4 | Acute systemic | None systemic toxicity | Pass |
| 5 | Genotoxicity | None genotoxicity | Pass |
| 6 | Implantation | Biocompatible | Pass |
| 7 | Chronic toxicity | No chronic toxicity | Pass |
Performance Bench Testing
| No. | Items | Acceptance Criteria | Reported Performance |
|---|---|---|---|
| 1 | Visual | No impurities and No specific changes | Pass |
| 2 | Capacity | Capacity error of; Standard Capacity |
§ 872.3690 Tooth shade resin material.
(a)
Identification. Tooth shade resin material is a device composed of materials such as bisphenol-A glycidyl methacrylate (Bis-GMA) intended to restore carious lesions or structural defects in teeth.(b)
Classification. Class II.